Calling the FDA’s bluff and saving smokers


In a recent Op-Ed for Reuters, FDA Commissioner Margaret Hamburg boasted about the success of the 2009 Family Smoking Prevention and Tobacco Control Act. The news would be quite welcome — if only it were true.

Unfortunately, the effectiveness of the new law’s various measures is nil. Its ban on candy cigarettes and requirement that cigarette makers divulge their ingredients will save exactly zero smokers. And the FDA’s recent attempt to impose large graphic health warning labels on cigarette packages and ads is another empty gesture: Most studies show that such graphic labels have no impact. Dr. Hamburg’s praise for the enforcement actions in the law would be appropriate, except that those rules were enacted first by the Tobacco Master Settlement Agreement in 1999.

Worse still, some of the prospective measures the FDA aims to implement will actually be counterproductive. For example, Hamburg claims that FDA researchers are aiming to reduce the addictiveness of tobacco products. However, reducing the level of nicotine will actually prove detrimental to smokers. A decrease in nicotine levels will likely cause smokers to smoke more cigarettes, thus inhaling more carcinogenic smoke, in order to get their nicotine fix.

The Tobacco Control Act also hurts public health by creating huge obstacles to tobacco harm reduction. Simply put, this method allows nicotine-addicted smokers to satisfy their craving with their drug of choice, but without the tobacco smoke that is the real killer. While nicotine keeps smokers coming back for more, it’s the smoke — inhaled hundreds of times a day — that causes the numerous smoking-related diseases.

Tobacco harm reduction is based on the same concept that led to the development of nicotine patches, gums and inhalers. Yet the sad fact is that the FDA-approved cessation products have been proven ineffective in study after study. The best of them increase “successful” quitting from 5 percent to maybe 10 percent — hardly anything to crow about. These products fail to deliver the nicotine “hit” that smokers require and do not replace the taste and rituals of smoking.

The options provided by tobacco harm reduction do — and they are simply more effective. In Sweden, a tobacco product called “snus,” smokeless tobacco sold in small teabag-like sachets, has been shown to help reduce smoking rates and smoking-related disease to the lowest level in Europe. Snus-type smokeless tobacco does not cause any of the cigarette-related diseases — and, of course, there is no secondhand smoke.

There are many other reduced-risk tobacco products and “clean-nicotine” devices as well. These include dissolvable oral orbs and sticks, and electronic cigarettes (“e-cigarettes”) that look like cigarettes but deliver a vapor of nicotine in a solution that is inhaled like cigarette smoke.

Given the recent uptick in smoking in less developed regions, one would expect public health leaders worldwide to embrace such promising technology. Alas, they haven’t. In fact, the international tobacco control treaty of 2003 (the World Health Organization Framework Convention on Tobacco Control) specifically urges governments not to investigate these nearly harmless and beneficial products, but to ban them first and develop reasons later.

No doubt, much of this resistance stems from the reprehensible activities of cigarette companies in decades past. But the goal now should be saving millions of American lives — and a billion others. The Centers for Disease Control and Prevention, American Cancer Society, FDA and others refuse to acknowledge that reduced-harm nicotine delivery products help smokers quit, whereas conventional FDA-approved patches and gum do not.

More than 450,000 lives are lost to smoking each year in our country alone, and multiples of that number are left too ill to work or enjoy life. The numbers are even more tragic in developing countries. Most smokers wish to quit, yet few succeed. All the while, our leaders issue platitudes and refuse to tell the truth. It is long past time that this should change. Smokers, and the families they leave behind, are the real victims of this public health embarrassment.

Dr. Gilbert Ross is executive and medical director for the American Council on Science and Health

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